Bringing new rotavirus vaccines quickly to market
PATH is helping advance the development of three new vaccines that could prove both affordable and effective in the developing world. One, the 116E human monovalent vaccine candidate, is being developed by the Indian manufacturer Bharat Biotech International Ltd. (BBIL). Seven emerging-country manufacturers and one US company are working on the second candidate, known as the bovine-human reassortant vaccine. The third, the monovalent RV3 vaccine candidate, is under development by Murdoch Childrens Research Institute (MCRI) in Australia.
Bharat Biotech International Ltd.
Since 2001, PATH has been part of a collaborative effort to develop and evaluate the 116E vaccine candidate, supporting BBIL to conduct Phase 1 and 2 clinical trials. This collaboration emerged from the Vaccine Action Program—a cooperative effort of the US and Indian governments—and drew on the seminal efforts of several leading experts in the rotavirus field. In India, we drew on the expertise of the Department of Biotechnology in the Ministry of Science and Technology (DBT), the Indian Institute of Science in Bangalore, the All India Institute of Medical Sciences in New Delhi, the National Institute of Immunology (NII), and the Society for Applied Studies (SAS). In the United States, we drew on the expertise of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and Stanford University. PATH is currently supporting BBIL to build manufacturing and quality control systems, including establishing a Good Manufacturing Practices-compliant assay laboratory and manufacturing facility. We are also supporting SAS and NII, in close collaboration with DBT and BBIL, to prepare for a Phase 3 efficacy trial.
Shantha Biotechnics Ltd. and China National Biotec Group's Wuhan Institute of Biological Products
PATH is closely partnering with two manufacturers—Shantha Biotechnics Ltd. in India (since 2007) and China National Biotec Group's Wuhan Institute of Biological Products (since 2007)—to provide financial support and scientific assistance to advance the development of the bovine-human reassortant vaccine (BRV) through Phase 1 and 2 clinical trials. The BRV candidate, containing components developed by NIH, is designed to protect against the four most common rotavirus disease strains, as well as two that are present in Asia and Africa.
In addition, PATH supports the emerging-country manufacturers actively developing the BRV candidate through a "shared technology platform" that provides a host of technologies, training, methodologies, and material. It is designed to meet common needs among emerging vaccine manufacturers. PATH is working with the following partners on specific components of the "shared technology platform":
- US National Institutes of Health
NIH developed components of the BRV and continues to play an advisory role in the vaccine's development. - Murdoch Children's Research Institute
MCRI is producing, qualifying, and making products (assays and reagents) available that test for purity and consistency in the various components of the vaccine. - Charles River Laboratories International, Inc.
Charles River Laboratories is performing testing to ensure that key vaccine ingredients, including virus seeds and other basic components, meet established international guidelines. - American Type Culture Collection
Vaccine manufacturers need cell cultures to grow the virus for vaccine production. American Type Culture Collection is providing the "starting material" cell banks (a qualified passage Vero cell line) that meets international standards for production of biological products. - Aridis Pharmaceuticals
Aridis Pharmaceuticals has developed liquid and spray-dried formulations of the BRV that will be offered to manufacturers as options for their formulations. - Impfstoffwerk Dessau-Tonau GmbH (IDT)
IDT is developing a production process for the BRV that will be made available to the manufacturers.
Murdoch Childrens Research Institute
In 2008, PATH formed a partnership with MCRI in Australia to support their further development of the RV3 vaccine candidate. PATH is assisting MCRI in the production of clinical trial lots of RV3 under Good Manufacturing Practices at Meridian Life Science in Memphis, Tennessee, in preparation for Phase 1 and 2 clinical trials to be conducted by MCRI.